FDA Approvals

Quotient Limited, a commercial-stage diagnostics company, headquartered in Eysins, Switzerland, announced that it has completed the process for declaring conformity to the essential requirements...

Gilead’s drug remdesivir gets US FDA’s emergency use authorisation for COVID-19

FDA Approvals

Gilead was granted EUA by U.S. FDA for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of remdesivir to...

FDA Grants Hardy Diagnostics Emergency Use Authorization (EUA) for a Rapid Antibody Test Kit for COVID-19

FDA Approvals

Hardy Diagnostics, a medical device manufacturer based in Santa Maria, California, announced FDA EUA approval on April 24th for a new in vitro diagnostic...

Recipharm supports FDA approval of Perrigos AB-rated generic product

FDA Approvals

Recipharm, a leading contract development and manufacturing organisation (CDMO), is pleased to note the FDA’s approval of Perrigo’s AB-rated generic of ProAir HFA (albuterol). Bespak...

Bridge Biotherapeutics Announces FDA IND Clearance for BBT-176, an EGFR TKI for NSCLC

FDA Approvals

Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, Republic of Korea, announced that the Investigational New Drug (IND) application submitted to...

Aptar Pharma’s Nasal Unidose Device Again Approved by US FDA for New Nasal Seizure Rescue Treatment

FDA Approvals

Aptar Pharma, a global leader in drug delivery systems, services and active packaging solutions, announced that its patented Unidose Liquid System is the device...

Ascletis Received Approval of Clinical Trials in HBV Patients for ASC22

FDA Approvals

Ascletis Pharma Inc announces the approval for ASC22 to conduct clinical trials in chronic hepatitis B patients in China from China's National Medical Products...

Subscribe Our Newsletter

White Papers

Whitepapers

FDA Approvals

About us

Resources

Advertise

Subscribe